MALDI Biotyper® MBT STAR®-Carba IVD Kit

The Bruker MALDI Biotyper® MBT STAR®-Carba IVD Kit is a diagnostic tool designed to detect beta-lactamase activity in bacterial isolates, extending the capabilities of the MALDI Biotyper® system beyond simple microbial identification. By identifying the enzymatic breakdown of beta-lactam antibiotics, this kit supports the rapid detection of resistance mechanisms, such as carbapenemase activity, essential for combating multidrug-resistant (MDR) bacteria.

Key Features

1. Beta-Lactamase Detection:
   • Analyzes hydrolysis of beta-lactam antibiotics, identifying enzymes responsible for antibiotic resistance.
   • Detects carbapenemase (via MBT STAR®-Carba) and cephalosporinase (via MBT STAR®-Cepha) activities.
2. Rapid Results:
   • Provides results within 30-60 minutes after co-incubation with beta-lactam antibiotics.
   • Time-efficient, enabling faster therapeutic decision-making.
3. User-Friendly Software:
   • The MBT HT STAR®-BL module automates signal computation and presents easy-to-interpret, color-coded results.
4. Broad Detection Spectrum:
   • Identifies beta-lactamase activities in:
     • Gram-negative Enterobacteriaceae
     • Pseudomonas spp.
     • Acinetobacter spp.
5. Comprehensive Reporting:
   • Results include visualized mass shifts indicating antibiotic hydrolysis and detailed interpretation of enzymatic activity.
6. Versatile Sample Compatibility:
   • Compatible with plate cultures or Sepsityper® pellets for sample preparation.

Applications

1. Antibiotic Resistance Detection:
   • Swift identification of resistance to carbapenems and third-generation cephalosporins.
   • Recognizes prevalent resistance mechanisms:
     • Class A, B, and D carbapenemases.
     • Extended-Spectrum Beta-Lactamases (ESBL).
     • AmpC beta-lactamases, including chromosomal and plasmid-mediated resistance genes.
2. Hospital and Clinical Microbiology Laboratories:
   • Enhances infection control strategies by identifying resistant pathogens.
   • Supports antimicrobial stewardship by reducing inappropriate antibiotic use.
3. Outbreak and MDR Surveillance:
   • Critical for tracking the spread of multidrug-resistant organisms within healthcare settings.
4. Research Applications:
   • The MBT HT STAR®-BL module for research supports studies on antibiotic resistance mechanisms.

Workflow and Methodology

1. Incubation:
   • Bacterial isolates are co-incubated with a beta-lactam antibiotic (e.g., carbapenem or cephalosporin).
   • If beta-lactamase is present, enzymatic hydrolysis of the antibiotic occurs.
2. Sample Preparation:
   • The sample is spotted onto a MALDI target plate for mass spectrometry analysis.
3. Mass Spectrometry:
   • The MALDI Biotyper® detects hydrolysis by measuring a mass shift of the antibiotic molecule.
4. Data Analysis:
   • The MBT HT STAR®-BL software evaluates signal intensities of hydrolyzed and intact antibiotics.
   • Results are plotted and presented in a user-friendly format with color-coded indicators.

Benefits

• Enhanced Diagnostic Speed: Reduces time-to-result for resistance detection compared to traditional phenotypic tests.
• Cost-Efficiency: Combines microbial identification and resistance testing on a single MALDI-TOF platform.
• Improved Patient Outcomes: Enables early intervention and appropriate antibiotic use.
• Global Compatibility: Available in CE-IVD workflows and for research use in non-clinical diagnostic settings.

Specific Use Cases

1. Carbapenemase Detection:
   • Detects carbapenemase-producing Enterobacteriaceae (CPE) and Acinetobacter spp. in clinical samples.
   • Example: Rapid confirmation of carbapenem resistance in ICU bloodstream infections.
2. Cephalosporin Resistance Monitoring:
   • Identifies resistance mechanisms in 3rd generation cephalosporins caused by ESBL or AmpC beta-lactamases.
   • Example: Tracking cephalosporin-resistant Klebsiella pneumoniae in an outbreak.
3. MDR Pathogen Screening:
   • Supports laboratories in monitoring multidrug-resistant pathogens for epidemiological studies.

Product Portfolio

1. MBT STAR®-Carba Kit (IVD):
   • Focuses on carbapenemase activity detection in clinical diagnostics.
2. MBT STAR®-Cepha Kit (IVD):
   • Identifies cephalosporin resistance for third-generation antibiotics.
3. MBT HT STAR®-BL Module:
   • Software for beta-lactamase activity evaluation (available for IVD-CE or research use only).

By combining microbial identification with resistance profiling, the Bruker MALDI Biotyper® MBT STAR® solutions empower laboratories to advance diagnostics and combat antibiotic resistance effectively.